Kikuchi T, Sugita S, Kondo U
… +11 more, Watanabe M, Matsumoto C, Nomura-Yogo M, Kunisada K, Sato K, Takei T, Ogura M, Abe Y, Hosoya O, Ishida T, Tsukada N
BACKGROUND: Elranatamab, a bispecific antibody targeting B-cell maturation antigen and CD3, has demonstrated efficacy in relapsed/refractory multiple myeloma (RRMM). However, real-world evidence is limited, and prognosti...BACKGROUND: Elranatamab, a bispecific antibody targeting B-cell maturation antigen and CD3, has demonstrated efficacy in relapsed/refractory multiple myeloma (RRMM). However, real-world evidence is limited, and prognostic factors have not been sufficiently evaluated. METHODS: We retrospectively analyzed patients with RRMM receiving elranatamab between June 2024 and July 2025. Responses were assessed using the International Myeloma Working Group criteria. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Prognostic factors were evaluated using univariate log-rank analysis, including R2-ISS at elranatamab initiation (dynamic R2-ISS) and modified MyCARe risk, with positivity defined as any detectable plasma cells in peripheral blood. RESULTS: Thirty-seven patients were evaluated (median age, 67 years; prior lines, 5). Median follow-up was 7.5 (median PFS, 9.7) months. One-year OS was 66.3%. The overall response rate was 67.6%, and 45.9% achieved at least a very good partial response. Extramedullary disease, plasma cells in the peripheral blood, and high-risk cytogenetics were adverse features. A baseline monocyte count < 300/µL, high-risk classification by modified MyCARe, and dynamic R2-ISS stage IV were significantly associated with shorter PFS and OS. CONCLUSION: Elranatamab was effective in real-world settings. Baseline monocyte count, modified MyCARe risk, and dynamic R2-ISS may serve as practical prognostic tools.
Uehara A, Narita K, Fujii F
… +7 more, Sakuma H, Oura M, Toho M, Ikeda D, Tabata R, Takeuchi M, Matsue K
Int J Hematol
· 2026 Mar · PMID 41329317
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This study characterized the phenotypic and cytogenetic features of circulating tumor plasma cells (CTPCs) in patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM)....This study characterized the phenotypic and cytogenetic features of circulating tumor plasma cells (CTPCs) in patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). A total of 120 patients were analyzed (MGUS, n = 70; SMM, n = 50). CTPCs were detected in 38.2% of MGUS and 61.8% of SMM. Immunophenotypic analysis based on mean fluorescence intensity revealed that CD200, CD117, CD38, CD56, and CD28 were significantly downregulated and CD45 was significantly overexpressed in CTPCs compared with BMPCs, whereas CD138 and CD81 expression levels did not differ. Cytogenetic analysis demonstrated higher prevalence of del(13q) and high-risk chromosomal abnormalities in CTPC-positive patients than CTPC-negative patients (24.0% vs. 4.5%, p = 0.048; 26.5% vs. 7.0%, p = 0.011, respectively). No significant differences were observed in other cytogenetic abnormalities including 1q gain/amplification, t(4;14), t(11;14), t(14;16), or del(17p). Serum soluble B cell maturation antigen levels did not differ between patients with or without detectable CTPCs in MGUS or SMM. These findings highlight the distinct phenotypic and cytogenetic characteristics of CTPCs in MGUS and SMM, and provide insights regarding their biological features and pathogenesis.
Mori Y, Kohno K, Ueno T
… +22 more, Odawara J, Kawano N, Nagafuji K, Harada T, Yoshimoto G, Kuriyama T, Urata S, Tanimoto K, Kikushige Y, Ogawa R, Ohno Y, Kamimura T, Ito Y, Takase K, Eto T, Fujisaki T, Tanimoto K, Katayama Y, Akashi K, Takenaka K, Miyamoto T, Fukuoka BMT Group
Int J Hematol
· 2026 Mar · PMID 41324785
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Cytomegalovirus (CMV) reactivation remains a major complication after hematopoietic cell transplantation (HCT), particularly in high-risk settings. Although the antigenemia (AG) assay has long been the standard CMV monit...Cytomegalovirus (CMV) reactivation remains a major complication after hematopoietic cell transplantation (HCT), particularly in high-risk settings. Although the antigenemia (AG) assay has long been the standard CMV monitoring tool in Japan, quantitative PCR (qPCR) offers improved sensitivity and is now widely adopted. We analyzed a total of 1878 samples from 231 HCT recipients who underwent CMV monitoring at multiple centers. We evaluated the correlation between AG and qPCR results, determined qPCR thresholds equivalent to AG positivity, and compared actual AG-guided therapy durations with simulated qPCR-guided therapy. Among 1878 sample sets, AG and qPCR showed strong correlation (r = 0.65) and high concordance (87.6%). Median qPCR values increased with AG positivity level. ROC analysis identified qPCR cut-offs corresponding to 2 and 10 AG-positive cells as 99.5 and 815 IU/mL, respectively. Of 57 qPCR-only episodes, 32 resolved without AG conversion; higher qPCR levels were associated with treatment need. Simulated qPCR-guided therapy durations closely matched AG-guided therapy (median 4 weeks), but some cases required longer treatment. qPCR-based CMV monitoring is concordant with AG and feasible for preemptive therapy. Careful interpretation of low-level viremia is warranted to avoid overtreatment. Further data are needed to refine qPCR thresholds in transplant settings.
Int J Hematol
· 2025 Nov · PMID 41318879
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JAK2V617F is the major driver mutation in polycythemia vera, and detection of this mutation is one of the most important keys for the diagnosis of this disease. In addition, JAK2V617F mutation is highlighted as a molecul...JAK2V617F is the major driver mutation in polycythemia vera, and detection of this mutation is one of the most important keys for the diagnosis of this disease. In addition, JAK2V617F mutation is highlighted as a molecular marker for monitoring treatment. Clinical studies of the JAK inhibitor ruxolitinib and two recently introduced new forms of alfa interferon, pegylated interferon alfa 2b and ropeginterferon alfa 2b, demonstrated that treatment with these agents induced a molecular response, defined as a more than 50% reduction in the JAK2V617F allele burden from baseline, in approximately 60% of patients. In addition, some patients achieved a complete molecular response, defined as the disappearance of the mutation. More importantly, achievement of a molecular response was positively correlated with improved thrombosis-free and progression-free survival in PV patients. To date, controlling hematological parameters, especially maintaining hematocrit levels below 45%, has been the gold standard surrogate endpoint in PV treatment. With new treatment options and knowledge, molecular response should be incorporated as a new therapeutic surrogate endpoint in the management of PV.
Takizawa J, Yoshida I, Ogawa Y
… +9 more, Toubai T, Kusumoto S, Watanabe M, Ogawa N, Satomi N, Nishimura Y, Honda H, Chyla B, Izutsu K
Int J Hematol
· 2026 Mar · PMID 41313523
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The development of effective and safe therapies for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in Japan remains a key focus of research. We conducted a phase 2, open-label, multicenter, non-compa...The development of effective and safe therapies for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in Japan remains a key focus of research. We conducted a phase 2, open-label, multicenter, non-comparative study to evaluate the safety and efficacy of fixed-duration venetoclax plus ibrutinib in 10 patients with previously untreated CLL/SLL (7 CLL/3 SLL). The primary endpoint was the rate of complete remission (CR)/CR with incomplete marrow recovery (CRi) assessed by the independent review committee (IRC). The median age was 72.5 (range 61-77) years. The IRC-assessed CR/CRi rate was 60.0% (95% confidence interval: 26.2-87.8%), exceeding the pre-specified efficacy threshold of 10% and meeting the primary endpoint. The median venetoclax treatment duration was 11.0 (range 2.1-17.7) months. At a median follow-up of 20.6 months, the secondary endpoints of median progression-free and overall survival were not estimated. The overall undetectable measurable residual disease rate was 60.0%. All patients experienced treatment-emergent adverse events (TEAEs), including 7 (70.0%) with grade 3/4 and 2 (20.0%) with serious TEAEs, respectively, and 1 discontinued venetoclax because of a TEAE (increased blood creatine phosphokinase). These findings suggest that venetoclax plus ibrutinib has a favorable benefit-risk profile with high efficacy and manageable safety.
Int J Hematol
· 2026 Apr · PMID 41296262
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T-cell lymphomas are clinically and biologically heterogeneous malignancies that comprise ~ 10% of non-Hodgkin lymphomas. Outcomes with first-line chemotherapy remain poor. Over the past decade, integrative genomic and e...T-cell lymphomas are clinically and biologically heterogeneous malignancies that comprise ~ 10% of non-Hodgkin lymphomas. Outcomes with first-line chemotherapy remain poor. Over the past decade, integrative genomic and epigenomic studies have defined recurrent abnormalities converging on proximal T-cell antigen receptor/costimulatory signaling to the NF-κB/NFAT, JAK/STAT, PI3K/AKT/mTOR, and NOTCH pathways, alongside pervasive alterations in chromatin modifiers and the DNA methylation machinery. In this review, we frame the biology of peripheral T-cell lymphoma as two interdependent layers, including genetic events that establish constitutive signaling programs and epigenomic remodeling that stabilizes these outputs. We overview genomic alterations across major peripheral T-cell lymphoma entities and analyze epigenomic dysregulation, focusing on DNA methylation, enhancer regulation, and polycomb-mediated gene control. We highlight adult T-cell leukemia/lymphoma as a paradigmatic dual-layer disease, summarize therapeutic approaches based on epigenetic traits, and discuss biomarker-guided strategies and challenges in translating integrated maps into durable disease control.
BACKGROUND: Heparinoid (Hirudoid®), a topical heparin-like agent, is labeled as contraindicated in bleeding disorders, yet its propensity for clinically relevant systemic anticoagulation remains uncertain. AIM: To assess...BACKGROUND: Heparinoid (Hirudoid®), a topical heparin-like agent, is labeled as contraindicated in bleeding disorders, yet its propensity for clinically relevant systemic anticoagulation remains uncertain. AIM: To assess heparinoid's anticoagulant potential in blood from healthy individuals and people with hemophilia (PwH). METHODS: In normal plasma exposed to heparinoid (≤ 6.5 μg/mL) or heparin, and in plasma from PwH supplemented with FVIII or FIX (0-50 IU/dL), we quantified activated partial thromboplastin time (APTT) and adjusted maximum coagulation velocity (Ad|min1|) by clot waveform analysis. In heparinoid-treated whole blood from healthy volunteers (≤ 9 μg/mL), clotting time (CT) and clot formation time (CFT) were assessed by rotational thromboelastometry. RESULTS: In normal plasma, heparinoid dose-dependently prolonged APTT and reduced Ad|min1|; at the estimated C (2.5 μg/mL), APTT increased ~ 1.2-fold and Ad|min1| approximated the effect of ~ 0.2 IU/mL heparin. In FVIII- or FIX-supplemented plasma from PwH, Ad|min1| showed a mild, factor-level-dependent decrease (~ 85% of control). In whole blood, CT + CFT changed minimally at therapeutic concentrations. Heparin controls provided an internal benchmark for assay sensitivity. CONCLUSION: At therapeutic levels, heparinoid exerts only mild anticoagulant effects in both normal and hemophilic matrices, supporting the view that topical use is unlikely to pose systemic bleeding risk in PwH.
Peripheral T-cell lymphomas (PTCLs) are biologically diverse and clinically aggressive, and are difficult to control long-term with conventional immunochemotherapy. Hematopoietic cell transplantation (HCT) is a key treat...Peripheral T-cell lymphomas (PTCLs) are biologically diverse and clinically aggressive, and are difficult to control long-term with conventional immunochemotherapy. Hematopoietic cell transplantation (HCT) is a key treatment option. Autologous HCT (auto-HCT) as first-line consolidation has shown durable progression-free survival in phase 2 studies and in the auto-HCT arm of the randomized AATT trial (intent-to-treat PFS 30-49%), although its routine use after complete metabolic response remains controversial. A phase 3 trial comparing auto-HCT with observation is ongoing. For relapsed/refractory PTCL, expert consensus supports allogeneic HCT (allo-HCT) as the treatment of choice for eligible patients, with early referral and limited salvage therapy. While complete remission is ideal, partial remission is acceptable. Upfront allo-HCT is not recommended for unselected PTCL in light of the results of the AATT trial, but adult T-cell leukemia-lymphoma (ATL) is an exception. Multiple studies have shown graft-versus-ATL effects, supporting allo-HCT in aggressive ATL. Donor sources now include unrelated and haploidentical donors, with outcomes comparable to matched siblings. Despite advances, relapse after HCT remains a major challenge. Novel maintenance strategies and optimized transplant approaches are needed to further improve outcomes in PTCL and ATL.
Int J Hematol
· 2025 Nov · PMID 41269494
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Immunotherapy has revolutionized cancer treatments, yet checkpoint inhibitors and CAR-T cells have shown limited efficacy in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). This limited efficacy is prim...Immunotherapy has revolutionized cancer treatments, yet checkpoint inhibitors and CAR-T cells have shown limited efficacy in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). This limited efficacy is primarily due to the absence of lineage-specific antigens and the presence of suppressive microenvironments. Innate immunity offers a promising alternative, as it acts independently of neoantigens. The key players such as macrophages, dendritic cells, and natural killer (NK) cells not only eliminate malignant cells but also remodel the microenvironment to enhance antileukemic activity. This review highlights recent advances in understanding innate immune mechanisms in AML and MDS and explores therapeutic strategies designed to leverage these pathways, aiming to broaden the scope of immunotherapy.
Konuma T, Hamatani-Asakura M, Monna-Oiwa M
… +6 more, Kato S, Andoh S, Ichimura H, Yokoyama K, Nannya Y, Takahashi S
Int J Hematol
· 2026 Mar · PMID 41264074
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Graft-versus-host disease (GVHD) is a major complication after allogeneic hematopoietic cell transplantation (HCT), and glucocorticoids remain the standard first-line treatment. However, glucocorticoid responses vary wid...Graft-versus-host disease (GVHD) is a major complication after allogeneic hematopoietic cell transplantation (HCT), and glucocorticoids remain the standard first-line treatment. However, glucocorticoid responses vary widely and are influenced by genetic polymorphisms in glucocorticoid signaling pathways. Their impact after cord blood transplantation (CBT) is unclear. We retrospectively analyzed adult patients who underwent single-unit CBT at our institution between 2005 and 2023 with available donor or recipient DNA. Genotyping of NR3C1 (rs33388) and GLCCI1 (rs37972, rs37973) was performed using TaqMan® assays. In univariate analyses, donor GLCCI1 rs37973 AG/AA genotypes were associated with a higher incidence of grades II to IV acute GVHD but a lower incidence of chronic GVHD compared with GG donors. Multivariate analysis confirmed that GLCCI1 rs37973 AG/AA donors had a significantly reduced risk of chronic GVHD (hazard ratio 0.57, 95% confidence interval 0.35-0.93, P = 0.025). Among 30 patients who developed grades III to IV acute GVHD treated with glucocorticoids, recipient NR3C1 rs33388 TT genotype was associated with significantly lower overall survival compared with AT/AA (24.4% vs. 63.5% at 5 years, P = 0.044). These findings suggest that donor GLCCI1 rs37973 and recipient NR3C1 rs33388 polymorphisms may influence GVHD risk and survival after CBT.
Nakaya Y, Yoshimura T, Hayashi T
… +3 more, Yoshida M, Hayashi Y, Nakao T
Int J Hematol
· 2026 Mar · PMID 41261350
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Evidence regarding the efficacy and safety of DeVIC (dexamethasone, etoposide, ifosfamide, and carboplatin) therapy for relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) is critically lacking. This retrosp...Evidence regarding the efficacy and safety of DeVIC (dexamethasone, etoposide, ifosfamide, and carboplatin) therapy for relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) is critically lacking. This retrospective study analyzed 78 patients with r/r DLBCL who received DeVIC therapy at a single institution. The overall response rate was 37.2%, comprising 21.8% complete and 15.4% partial responses. A total of 15 (19.2%) patients proceeded to transplantation or cellular therapy. The 3-year overall survival and progression-free survival were 28.2 and 18.0%, respectively. Multivariable analyses identified refractoriness to prior therapy and elevated serum lactate dehydrogenase (LDH) levels as significant predictors of poor response and survival. Decision tree models confirmed these findings, revealing that relapsed cases with low LDH had the most favorable outcomes. Hematological toxicities were frequent, with febrile neutropenia in 52.6% and infection-related mortality in 3.8% of patients. Those with central nervous system involvement had a dismal prognosis, underscoring the need for novel therapeutic approaches. These findings highlight the potential role of DeVIC therapy in selected patients with r/r DLBCL and provide insights into optimizing bridging strategies and subsequent immunocellular therapies.
Recent therapeutic advances, including immunomodulatory drugs, proteasome inhibitors, monoclonal antibodies, bispecific antibodies, and chimeric antigen receptor-T-cell therapies, have transformed the treatment landscape...Recent therapeutic advances, including immunomodulatory drugs, proteasome inhibitors, monoclonal antibodies, bispecific antibodies, and chimeric antigen receptor-T-cell therapies, have transformed the treatment landscape of multiple myeloma (MM). Beyond direct cytotoxicity, these agents profoundly reshape the bone marrow immune microenvironment, which plays a decisive role in disease initiation, progression, and therapeutic response. MM cells thrive within this specialized niche by recruiting and reprogramming regulatory T cells, myeloid-derived suppressor cells, dendritic cells, and macrophages to suppress antitumor immunity while simultaneously driving functional exhaustion of effector T cells and impairing natural killer cell cytotoxicity. Accumulating evidence demonstrates that these immune alterations emerge even at precursor stages, such as monoclonal gammopathy of undetermined significance and smoldering MM, progressively intensifying disease evolution. In this review, we synthesize recent insights into immune cell dynamics during MM progression, highlighting both regulatory and effector compartments. We further discuss how contemporary therapies modulate these immune interactions, underscoring their dual roles in fostering immune activation while, at times, sustaining immunosuppressive pathways. A comprehensive understanding of the immune landscape in MM will be critical to optimizing existing treatments, overcoming therapeutic resistance, and guiding the development of next-generation immunotherapies.
Tashiro Y, Jo T, Kitawaki T
… +9 more, Yoshinaga N, Sakamoto T, Shirakawa K, Kanda J, Nishikori M, Yamashita K, Nagao M, Takaori-Kondo A, Arai Y
Int J Hematol
· 2026 Mar · PMID 41247641
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Although chimeric antigen receptor (CAR)-T cell therapies are highly effective for B-cell lymphoma, they frequently cause cytokine release syndrome (CRS). High-grade CRS is serious and may require intensive care, yet rel...Although chimeric antigen receptor (CAR)-T cell therapies are highly effective for B-cell lymphoma, they frequently cause cytokine release syndrome (CRS). High-grade CRS is serious and may require intensive care, yet reliable early predictive markers remain elusive. To identify risk factors for high-grade CRS, we retrospectively analyzed B-cell lymphoma patients who received CD19 CAR-T cell therapy. Of 106 patients analyzed, CRS occurred in 93 (88%), Grade ≥ 2 CRS in 28 (26%), and Grade ≥ 3 CRS in 6 (6%). Reticulocyte counts at infusion were significantly lower in patients who developed Grade ≥ 2 CRS (1.85 vs. 2.80 × 10/µL, p = 0.02). Multivariate analysis identified low reticulocyte count (< 15,000/µL; HR 2.21; 95% CI 1.01-4.86; p = 0.048), high metabolic tumor volume (> 100 mL), and use of axicabtagene ciloleucel as independent risk factors for Grade ≥ 2 CRS. Stratification by the reticulocyte cutoff showed higher 30-day cumulative incidence of CRS in patients with low counts, for both Grade ≥ 2 (42.9% vs. 19.7%, p = 0.012) and Grade ≥ 3 CRS (17.9% vs. 1.3%, p < 0.001). KyoTox-CRS, a risk-scoring system integrating these factors, effectively stratified these CRS risks. Early prediction of high-grade CRS based on the reticulocyte count at infusion may help to guide optimal risk-based management of CAR-T cell therapy.
Shimada T, Takahata A, Tanaka K
… +1 more, Toyota S
Int J Hematol
· 2026 Mar · PMID 41247640
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Venetoclax (VEN) has emerged as a frontline therapy for older adults with acute myeloid leukemia (AML), yet its advantages over intensive chemotherapy (IC) remain uncertain. This single-center retrospective study compare...Venetoclax (VEN) has emerged as a frontline therapy for older adults with acute myeloid leukemia (AML), yet its advantages over intensive chemotherapy (IC) remain uncertain. This single-center retrospective study compared the efficacy and safety of VEN-based regimens (n = 35) with IC (n = 54) in newly diagnosed patients with AML aged ≥ 65 years. No significant differences were found in the primary endpoints of median event-free survival (190.0 vs. 84.5 days, p = 0.20) or median overall survival (324 vs. 273 days, p = 0.30). However, the VEN group demonstrated a significantly higher overall response rate (71% vs. 48%, p = 0.03) and a more favorable safety profile. Notably, 30-day mortality was 0% in the VEN group compared to 16.7% in the IC group. Rates of Grade ≥ 3 cytopenias and febrile neutropenia were also significantly lower in the VEN group. These findings suggest that VEN-based regimens offer comparable survival with improved response rates and reduced early mortality, supporting their use as an effective and safer alternative to IC even for some IC-eligible older adults with AML, though these conclusions are drawn from a single-center, retrospective study.
Int J Hematol
· 2026 Jun · PMID 41247639
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Chronic graft-versus-host disease (cGVHD) is a leading cause of late morbidity and mortality after allogeneic hematopoietic cell transplantation. Corticosteroids remain the standard first-line therapy; however, many pati...Chronic graft-versus-host disease (cGVHD) is a leading cause of late morbidity and mortality after allogeneic hematopoietic cell transplantation. Corticosteroids remain the standard first-line therapy; however, many patients develop steroid-refractory or steroid-dependent disease, underscoring the need for more effective and better-tolerated treatments. Ruxolitinib has emerged as the most evidence-supported option for steroid-refractory cGVHD, with the phase 3 REACH3 trial demonstrating higher response rates, durable disease control, and clinically meaningful improvements in symptom burden compared with best available therapy. Belumosudil and axatilimab have also shown encouraging efficacy and safety in heavily pretreated populations. The addition of novel agents to standard corticosteroid-based therapy has been explored in clinical trials. Interest in combination strategies, such as ruxolitinib with extracorporeal photopheresis or belumosudil, is increasing, though prospective studies are required to define their role. Key challenges include optimizing long-term safety, mitigating infectious complications, and preserving the graft-versus-leukemia effect. This review summarizes current therapeutic strategies and discusses evolving treatment algorithms, emphasizing practical considerations in therapy selection. Approaches targeting specific pathogenic mechanisms, combining agents with distinct mechanisms of action, and incorporating biomarker-driven strategies are expected to further improve outcomes and quality of life for patients with cGVHD.
Liu X, Zhong J, Luo M
… +5 more, Gu X, Liu J, Liu Z, He J, Li Y
Int J Hematol
· 2026 Jan · PMID 41240289
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Chronic myeloid leukemia (CML) is characterized by the BCR::ABL1 fusion gene, resulting from Philadelphia (Ph) chromosome rearrangements that generate abnormal t (9; 22)(q34;q11) translocations. The most common fusion va...Chronic myeloid leukemia (CML) is characterized by the BCR::ABL1 fusion gene, resulting from Philadelphia (Ph) chromosome rearrangements that generate abnormal t (9; 22)(q34;q11) translocations. The most common fusion variants are e13a2 and e14a2. We diagnosed a case of CML with the rare e8a2 fusion variant using real-time quantitative PCR and sequencing. Although the e8a2 variant is increasingly reported in CML, comprehensive retrospective analyses remain scarce. Through a systematic review of published e8a2 BCR::ABL1 cases, we summarized the classification, treatment outcomes, and prognostic characteristics associated with this rare genotype. This analysis aims to provide additional evidence to facilitate improved diagnosis and therapeutic strategies for e8a2-positive CML patients.
Komatsu N, Ito K, Arita K
… +2 more, Mitobe Y, Mitsui H
Int J Hematol
· 2026 Mar · PMID 41239076
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Iron absorption after the administration of oral iron preparations following a meal is generally reduced compared with fasting. The aim of this study was to investigate the effect of food on iron absorption following fer...Iron absorption after the administration of oral iron preparations following a meal is generally reduced compared with fasting. The aim of this study was to investigate the effect of food on iron absorption following ferric citrate hydrate administration in patients with iron deficiency anemia. A randomized, open-label, two-cohort, two-period, single-dose crossover study was conducted to assess the effect of food on iron absorption when 500 mg ferric citrate hydrate (approximately 120 mg of ferric iron) was administered under fasted and fed (immediately after a meal) conditions. Twelve patients aged 20-45 years with iron deficiency anemia (hemoglobin: male 8.0-13.0 g/dL, female 8.0-12.0 g/dL; serum ferritin < 12 ng/mL; transferrin saturation ≤ 16%), participated. The maximum serum iron concentration change was defined as ΔC, and the area under the serum iron concentration change versus time curve from baseline to 24 h after administration as ΔAUC. Serum iron levels increased regardless of fasting or fed conditions, and the ΔC and ΔAUC values were 39% and 29% higher, respectively, under fed versus fasting conditions. No adverse events were reported. In conclusion, food had no notable effect on iron absorption following ferric citrate hydrate administration in patients with iron deficiency anemia.